Intraoperative Stability Assessment of the First Carpometacarpal Joint
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Primary thumb stability in newton measured with DaSta
研究概览
简要总结
The goal of the current study is to objectively measure intraoperative the initial thumb stability after trapezium removal when performing trapeziectomy, alone or in combination with suspension and tendon interposition and to evaluate if there are differences in the stability between the patients and with the different surgical steps. Additionally, the subjective stability rating of the surgeon will be compared with the objective measures and if there is a correlation between clinical/patient-related parameters and the measured intraoperative stability.
详细描述
Osteoarthritis of the first carpometacarpal joint (CMC I OA) treatment strategies typically focus on pain relief and restoring motion and function. Besides different other treatment modalities, such as trapeziectomy (removal of the trapezium bone) alone, the resection-suspension-interposition arthroplasty (after trapezium resection additional stabilisation with a tendon strip) (LRTI) are the most popular interventions. When performing trapeziectomy, alone or in combination with suspension and tendon interposition, the surgeon perceives individual differences in joint stability. However, there are no quantitative data available on the stability of the CMC I joint after trapeziectomy. Furthermore, the relative contribution of the different surgical steps to the stability of the joint is unknown. The goal of the current study is to objectively measure intraoperative thumb stability and evaluate if there are differences in the stability between the patients and with the different surgical steps. Additionally, the subjective stability rating of the surgeon will be compared with the objective measures. Additionally, the subjective stability rating of the surgeon will be compared with the objective measures and if there is a correlation between clinical/patient-related parameters and the measured intraoperative stability.
Procedure 1: Patient enrollment
During the preoperative consultation, the surgeon identifies patients which meet the inclusion criteria. Before any study specific examinations are performed, the patient has to give written informed consent to participate in the study according to the clinical investigation protocol. Patients will have enough time to decide for or against participation until before the surgery (usually one-six weeks after the consultation).
Baseline data:
After inclusion in the study, documented by patient informed consent, the following data will be collected:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with primary trapeziometacarpal osteoarthritis in the thumb and indication for LRTI surgery
- •Indication for Trapeziectomy alone
- •Informed Consent as documented by signature
- •Patient aged 18 years and over
排除标准
- •Previous surgeries of the affected CMC I joint
- •Inflammatory disease (e.g. rheumatoid arthritis)
- •Tumour / malignoma
- •German language barrier to complete the questionnaire
- •Any disease process that would preclude accurate evaluation (e.g. neuromuscular, psychiatric or metabolic disorder)
- •Legal incompetence
- •Indication for pyrocarbon implant
结局指标
主要结局
Primary thumb stability in newton measured with DaSta
时间窗: intraoperative period
Objective primary thumb stability after trapeziectomy measured in newton (kg\*m/s2) with the DaSta measurement system
次要结局
- Thumb stability in newton measured with DaSta after suspension, interposition and joint capsule closure(intraoperative period)
- Qualitative primary thumb stability in 3 point rating scale(intraoperative period)
- Correlation and relationship between all patient-related and clinical parameters with the measured stability(Pre Operation)